Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| ASBM Whitepaper: Misinformation About Interchangeable Biosimilars Undermines US Health Policy, Physician Confidence, and Patient Health On July 16th, GaBI Journal published a whitepaper authored by ASBM Chairman Ralph McKibbin, MD and Executive Director Michael Reilly, which underscores the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health,” the paper discusses the successes of the FDA’s data-driven approach in building physician and patient confidence in biosimilars and provides an analysis of the potential risks associated with weakening these proven standards. In the U.S. as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S., only biosimilars deemed “interchangeable” by the FDA may be substituted by a pharmacist. 13 of the 53 approved biosimilars have earned that designation by providing additional data to the FDA demonstrating no loss of safety or efficacy even following multiple switches between a reference biologic and the biosimilar. This data may or may not include a switching study; several interchangeables have been approved without them. “All FDA-approved biosimilars are safe and effective, but treatment plans are not one-size-fits-all”, says McKibbin. “Each is uniquely tailored, and patients frequently try several products before finding one that best stabilizes their condition. Physicians need to be confident that a substitution by a pharmacy or insurance company won’t disrupt the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance.” “While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% believe only the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company”, notes Reilly. “These views are shared by physicians worldwide. But when a biosimilar carries an interchangeable designation, the majority (59%) of U.S. physicians are more comfortable with a pharmacy-level substitution because of the additional safety and efficacy data. The FDA’s standards are working, and any effort to lower them could compromise the progress we’ve made in building physician and patient confidence in biosimilars.” The publication of this paper comes at a critical time as the FDA seeks public comment on recent draft guidance that proposes to lower the data requirements for demonstrating interchangeability, and the U.S. Senate is considering a bill that would deem all biosimilars interchangeable and severely restrict the FDA’s ability to ask for additional data. The paper critically examines the recent meta-analysis often cited by proponents of lowering these standards. Focusing on safety but neglecting efficacy impacts and extrapolating multi-switch safety from mostly single-switch studies, McKibbin and Reilly argue the data do not support the proposed policy change. Read ASBM’s statement about the paper’s release here. Read the full paper here. |
| COMMENT PERIOD OPEN: FDA Draft Guidance Proposes Eliminating Switching Studies for Interchangable Biosimilars On June 20th, the FDA released new draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. In a statement, Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars said: “The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science.” From the FDA’s statement: FDA has generally recommended switching studies in the past as part of the data package needed to demonstrate interchangeability of a biosimilar; however, of the 13 approved interchangeable biosimilars, 9 were approved without additional clinical (switching study) data. With the publishing of today’s draft guidance, FDA is seeking comment on a revised approach where such studies will generally not be needed. The FDA is accepting public comment on the draft guidance from stakeholders until August 20, 2024. ASBM will be submitting comments and encourages others in the patient advocacy community to do so as well. Interested parties may submit their own comments here. The role and value of switching studies in the approval of interchangeable biosimilars has been a subject of much discussion recently, and ASBM has generated several educational resources on the subject. On November 30th, 2023 ASBM cohosted a webinar with GaBI November 30th on the topic. On May 10th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published an article by ASBM’s Executive Director Michael Reilly entitled “Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars”, which sought to address a recent push by U.S. policymakers to weaken or undermine the standard. In the article, Reilly explains the importance of additional data in building physician confidence: “The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.” Read ASBM’s whitepaper about how misinformation regarding interchangeable biosimilars is undermining U.S. policy here. View the webinar on Interchangeable Biosimilars here. Read the article in GaBI Journal here. Submit comments on the draft guidance by August 20, 2024 here. |
| ASBM Fact Sheet: Senate Bill S.2305 Would Require FDA to Deem ALL Biosimilars Interchangeable, Restrict FDA From Considering Switching Studies to Establish Safety and Efficacy After Switching In July, ASBM released a fact sheet on Senate Bill S. 2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Mike Lee (R-UT). From the Fact Sheet: S. 2305 would inappropriately eliminate the FDA safeguards now required for the pharmacy substitution of biosimilars. This would undermine physician confidence, risk treatment stability for millions of patients, and give PBMs and insurance companies control of treatment decisions that should be made by physicians and patients. U.S. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% also say the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. That’s because treatment plans aren’t one-size-fits-all. Each is uniquely tailored, and patients frequently try several products before finding one that best stabilizes their condition. Physicians need to be confident that a substitution by a pharmacy or insurance company won’t disrupt the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance, making a majority (59%) of U.S. physicians more comfortable with a pharmacy-level substitution. From 2013-2021 all 50 state legislatures passed laws restricting automatic pharmacy substitution of biosimilars ONLY to interchangeable biosimilars. These laws were passed with the support of state medical societies and patient organizations, conditional on these limits. S.2305 would classify ALL biosimilars as interchangeable-inappropriately permitting generic-style pharmacy substitution by insurance companies and pharmacy benefit managers, without the safety and efficacy data now needed. This would jeopardize treatment stability for millions of patients and betray the assurances made to physicians and patients nationwide that only biosimilars which had provided additional safety and efficacy data would ever be substituted without physician approval. It would also restrict what data FDA can ask for to approve an interchangeable biosimilar, requiring the HHS Secretary to hold a private briefing with the chairs and ranking members of the Senate HELP and House Energy and Commerce Committees to justify asking for a study demonstrating switching won’t reduce safety or efficacy in patients. Read the full Fact Sheet here. |
| ASBM to Update Ohio State University Biosimilars Course In the coming weeks, ASBM will announce updates to its 7-part Biosimilars Continuing Education Course produced in cooperation with Ohio State University College of Pharmacy. ASBM Chairman Ralph McKibbin and Advisory Board Chair Philip Schneider will be recording the first of the updated course modules (Biosimilars Module 2: Substitution and Interchangeability) in the coming weeks. The course is fully ACPE-accredited and available to pharmacists nationwide for 7 hours of CE credit. “Much has happened in the past year or two regarding biosimilar substitution; particularly regarding the role of interchangeable biosimilars,” said Schneider. “As the healthcare provider responsible for substitution, it’s important that pharmacists are kept up to date with accurate information.” Schneider, a professor at OSU’s College of Pharmacy, will also record a 5-minute promotional video for the course, previewing some of the updates regarding interchangeable biosimilars. ASBM will share this video when it becomes available. |
| BIO 2024: ASBM Participates in Annual Biotechnology Conference From June 3rd-6th, the Biotechnology Innovation Organization held its Annual International Conference in San Diego, CA. ASBM was well represented at the conference, with several member groups in attendance including AiArthritis, the Alliance for Patient Access, and the Lupus and Allied Diseases Association. Executive Director Michael Reilly also attended in the conference, where he participated in educational sessions and met with representatives of the biotechnology industry and patient advocacy communities. A key topic of discussion included the effects of the Inflation Reduction Act (IRA), which is expected to disincentivize drug research in the coming years, ultimately reducing patient access to new innovative therapies. ASBM has developed a number of educational resources discussing these themes: View ASBM’s IRA patient education microsite IRAPatientInfo.org here. View ASBM’s educational resource guide on the IRA for patient access here. |
| Forbes: IRA’s Small Molecule Price Controls Are Short Sighted On June 24, Forbes published an op-ed by Pacific Research Institute President Sally Pipes discussing the IRA’s highly controversial “small molecule penalty” and in particular its negative consequences for cancer research: AstraZeneca’s Tagrisso “can contain lung cancer nearly three years longer than chemotherapy and radiation alone.” Pfizer’s Lorbrena helps keep 60% of advanced lung cancer patients “alive without their disease advancing at five years,” compared to just 8% of patients who hit that milestone after taking a similar, older drugs.We’re likely to see fewer of these innovative drugs hit the market in the years to come, thanks to the Democrats’ Inflation Reduction Act, which President Biden signed into law in 2022. Starting in 2026, ten drugs under Medicare’s Part D prescription drug benefit will be subject to government price controls. Medicare will cap the prices of steadily more drugs dispensed via Part D and the Part B physician services program in the years that follow.Companies that refuse to sell at government-ordered prices may either withdraw from Medicare and Medicaid — a non-starter given that the government covers roughly half of all healthcare expenses. Or they can pay an excise tax that could reach up to 95% of the drug in question’s sales.Price controls are disincentive enough to invest in the development of new cancer drugs. But the IRA also targets the types of drugs that most commonly treat cancer for price controls four years sooner than it does biologics. Read the full op-ed here. |
| UPCOMING EVENTS ACR Convergence 2024 Washington, DC – November 14-19, 2024 WHO 79th INN Consultation Geneva, Switzerland – October 22, 2024 |
